Method for detecting hematoma, portable detection and discrimination device and related systems and apparatuses

ABSTRACT

Featured are methods, apparatus and devices for detecting a hematoma in tissue of a patient. In one aspect, such a method includes emitting near infrared light continuously into the tissue from a non-stationary near infrared light emitter and continuously monitoring the tissue using a non-stationary probe so as to continuously detect reflected light. The near infrared light is emitted at two distances from a brain of the patient, so the emitted light penetrates to two different depths. Such a method also includes applying a ratiometric analysis to the reflected light to distinguish a border between normal tissue and tissue exhibiting blood accumulation.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/516,480, filed 1 Feb. 2013, which is a 35 U.S.C. § 371 U.S. nationalentry of International Application PCT/US2010/060506 (WO2011/084480)having an International filing date of 15 Dec. 2010, which claims thebenefit of U.S. Provisional Application Ser. No. 61/286,626, filed 15Dec. 2009, all of which are incorporated herein in their entireties byreference.

FIELD OF INVENTION

The present disclosure generally relates to methods, devices andapparatuses for detecting a hematoma, such as a subdural hematoma, moreparticularly to methods, devices and apparatuses for detecting anintracranial hematoma and yet more particularly to methods, devices andapparatuses for detecting and discriminating a hematoma.

BACKGROUND OF THE INVENTION

A hematoma is a localized collection of extravasated blood (e.g., bloodfrom a ruptured blood vessel or the like), usually clotted, in an organ,space, or tissue; bruises and black eyes are familiar forms that areseldom serious. Hematomas can occur almost anywhere on the bodyincluding inside the skull, and are almost always present with afracture; in minor injuries the blood is absorbed unless infectiondevelops.

Hematomas inside the skull are particularly serious, because they canproduce local pressure on the brain. The two most common kinds of theseare epidural (outside the brain and its fibrous covering, the dura, butunder the skull) and subdural (between the brain and its dura). Othertypes of hematomas occurring inside the skull include intracerebral (inthe brain tissue) and subarachnoid (around the surfaces of the brain,between the dura and arachnoid membranes). Such hematomas can resultfrom a number of causes such as head injury or head trauma as well asdue to bleeding disorders or an aneurysm.

Subdural hematomas are usually the result of serious head injury. When asubdural hematoma occurs this way, it is typically called an acutesubdural hematoma. Acute subdural hematomas are among the deadliest ofhead injuries as the bleeding fills the brain area very rapidly, therebycompressing brain tissue, which can lead to brain injury. Also, risk fora subdural hematoma can be increased by one of more of the following;taking anticoagulation medication (e.g., blood thinners includingaspirin), long term alcohol abuse, recurrent falls, and repeated headinjury. Risk also is increased for the very young and the very old.

Subdural hematomas also can occur from a minor head injury, especiallywhen the injured is elderly. Such hematomas can go unnoticed for a longperiod of time (e.g., many days to weeks) and are often called a chronicsubdural hematoma. With any subdural hematoma, tiny veins between thesurface of the brain and its dura stretch and tear, allowing blood tocollect. In the elderly, such veins are often stretched because of brainatrophy or shrinkage and thus are more easily injured.

Because of the negative consequences associated with hematomas insidethe head or skull, it is necessary to be able to identify and locatesuch hematomas inside the skull, such that appropriate medical andsurgical procedures (e.g., evacuation of the hematoma) can be timelyundertaken so as to reduce the chances for mortality and/or worsenedoutcome in survivors. Such timely undertakening is on the order of about4 hours from occurrence of the injury and the evacuation of thehematoma.

CT scanning is one imaging technique that can be used to identify andlocate traumatic intracranial hematomas. However, all medical facilities(e.g., trauma centers) do not necessarily have immediate CT scanningcapability on a 24/7 basis and thus it may not be possible in such casesfor a CT scan to be performed so that an identified hematoma can beevacuated within the desired time frame. Also, in emergencies involvinghead trauma in underdeveloped areas of the world, areas in the US whichhave limited access to trauma centers having 24/7 CT scanning capabilityor in areas of the US or the world (e.g., a battlefield) having traveltime issues from the site of the injury to the treatment facility;timely identification of patients that require surgery for dealing withthe hematoma can be more difficult. Thus, in such settings where a CTscan cannot be performed with the desired time frame, the primary methodfor identification of patients with hematomas is by means of aneurological exam.

A neurological exam, however, is a poor substitute for a CT scan becauseno single physical sign can reliably indicate the presence of ahematoma. Focal neurological findings are found in only a fraction ofpatients with surgical hematomas. Coma has been reported to occurwithout the occurrence of a surgical hematoma in a large percentage ofpatients with sever head injury. Although patients with an intracranialhematoma will exhibit increased intracranial pressure (ICP), edema ofthe optic disk (papilledema), associated with ICP, is uncommon afterhead injury.

There is found in U.S. Pat. No. 5,954,053, systems that utilizedifferential measurement of radiation that has migrated throughmigration paths between two source-detector pairs placed on the head ina manner that each path is localized in a portion of one hemisphere ofthe brain. Various spectrophotometer systems are also shown for in vivoexamination of tissue of a human by measuring changes in electromagneticradiation scattered and absorbed in a migration path in the tissue.Generally, the spectrophotometer systems comprise a light source forintroducing the radiation into the tissue, a detector for detectingradiation that has migrated in the tissue, a processor for processingsignals of the detected radiation to create processed data, and a systemfor determining physiological or pathophysiological changes in thetissue of interest such as bleeding or tumor.

There is found in U.S. Pat. No. 7,139,603, methods and systems thatexamine tissue positioned between input ports and a detection port. Atlease one light source of a visible or infrared wavelength is providedthat introduces electromagnetic radiation into the subject. Thedetection port is optically coupled to a detector that is connected to adetector circuit. Radiation intensities are selected for introduction atthe input ports to define a null plane in the tissue. The detection portis positioned relative to the null plane. Radiation is introduced intothe subject at the first input port and the radiation that migratesthrough the tissue is detected. The detector circuit stores a firstdetector signal corresponding to the first detected radiation. Radiationis introduced at the second input port and is detected. The firstdetector signal is subtracted from a second detector signalcorresponding to the second detected radiation to obtain processed data.

There is found in U.S. Pat. No. 7,610,082, an optical examinationtechnique that employs an optical system for in vivo non-invasivetranscranial examination of brain tissue of a subject. The opticalsystem includes an optical module arranged for placement on the exteriorof the head, a controller and a processor. The optical module includesan array of optical input ports and optical detection ports located in aselected geometrical pattern to provide a multiplicity of photonmigration paths inside the biological tissue. Each optical input port isconstructed to introduce into the examined tissue visible or infraredlight emitted from a light source. Each optical detection port isconstructed to provide light from the tissue to a light detector. Thecontroller is constructed and arranged to activate one or several lightsources and light detectors so that the light detector detects lightthat has migrated over at least one of the photon migration paths. Theprocessor receives signals corresponding to the detected light and formsat least two data sets, a first of said data sets representing bloodvolume in the examined tissue region and a second of said data setsrepresenting blood oxygenation of the examined tissue. The processor isarranged to correlate the first and second data sets to detect abnormaltissue in the examined tissue.

There is found in International Publication No. WO 2006/121833, a systemand method for determining a brain hematoma including a handheld devicefor emitting and detecting radiation with a removable light guideassembly. The method for determining a brain hematoma condition includesdetermining optical density of various regions of the brain using nearinfrared spectroscopy.

In the above identified International Publication, the described deviceis positioned at a specific location of the head and data is acquiredusing the device. After acquiring data at this location, the device isre-located to another location of the head and another set of data isacquired at the new location. This relocation of the device andacquiring a set of data is repeated until the device has been placed atall possible or desired locations of the head.

It thus continues to be desirable to provide methods, devices,apparatuses for detecting hematomas in tissues of a patient. Moreparticularly it continues to be desirable to provide such methods,devices and apparatuses for detecting and identifying a hematoma, yetmore particularly the type of hematoma inside the head of the patient.It also would be desirable to provide such methods, device andapparatuses that allow a clinician. medical personnel, emergency medicaltechnician, medic/coreman or the like to detect such a hematoma withoutrequiring the use of sophisticated imaging systems or techniques such asCAT scan or MRI systems and in a wide range of settings includinghospital ER settings and usage in the battlefield, rural areas or inless developed areas of the world. Such devices preferably would besimple in construction and less costly than prior art devices and suchmethods would not require highly skilled users to utilize the device.

SUMMARY OF THE INVENTION

The present disclosure features methods, apparatus and devices fordetecting a hematoma in tissue of a patient. Such methods, apparatus anddevices advantageously provide a mechanism for detecting hematomas suchas an intracranial arachnoid hemorrhage (SAH) or subdural hematoma (SDH)not otherwise detectable without the use of highly skilled cliniciansand/or large scale imaging scanners such as MRI scanners and CATscanners. Such methods and devices of the present disclosure also areadvantageous as they allow the clinician, medical personnel, EMT ormedic to perform an initial assessment of patient in a wide range ofsettings as well as with relatively speaking short enough time periodsafter occurrence of the accident or injury so as to minimize the risk ofdeath or complications.

Such methods, apparatuses and devices of the present disclosure providesa triage tool to prioritize expensive CT scans. If the use of the devicereduces the need for CT scans by 5% for example, the cost savings wouldhugely beneficial. Also, because of the relatively small size of adetection device according to the present disclosure, the device alsowould be advantageous in combat critical care or third world caresituations where CT scan may not be readily available. In such cases theability to roughly locate the center of a hematoma using the detectiondevice of the present disclosure provides a means for localizing thehematoma for surgical intervention and thus improving the ability tosave a life from a hematoma type injury.

According to an aspect of the present disclosure, there is featured amethod for detecting a hematoma. Such a method includes emitting nearinfrared light and directing the emitted light towards tissue of apatient, measuring reflected light corresponding to two depths ofpenetration, obtaining a ratiometric measure of the reflected lightcorresponding to the two depths of penetration; and determining from theobtained ratiometric measure at least the presence of a blood event.Such a blood event is representative of a blood-tissue injury and moreparticularly includes an intracranial arachnoid hemorrhage a subduralhematoma or an epidural hematoma.

In embodiments, such methods further include moving an emitter of thenear infrared light and a reflected light detection section fordetecting the reflected light along an external surface of the tissue,and performing said steps of emitting, measuring and determining duringsaid step of moving.

In such methods, the ratiometric measure is representative of a ratio ofdensities representing the reflected light of the two penetrationdepths. Also such determining includes evaluating the ratiometricmeasure to distinguish between normal tissue and tissue exhibiting bloodaccumulation.

In yet further embodiments, such methods further include providing adetection device including a near infrared light emitting section and areflected light detection section. The near infrared light emittingsection is configured and arranged so that the near infrared light beingemitted penetrates to two different depths in the patient and thereflected light detection section is configured and arranged so as toseparately detect reflect light being reflected from the two depths. Inmore particular embodiments, the near infrared light emitting section isconfigured and arranged so as to emit a first light having a wavelengthat or about a first wavelength, the first light penetrating to a firstdepth and to emit a second light having another wavelength at or about asecond wavelength, the second light penetrating to a second depth andthe reflected light detection section is configured and arranged toseparately detect reflected light corresponding to the first light andreflected light corresponding to the second light.

In yet more particular embodiments, the first wavelength and the secondwavelength are on either side of 800 nm. Alternatively, the first lighthas a wavelength longer than 800 nm and the second light has awavelength shorter than 800 nm.

In yet more particular embodiments, the emitter/emitting sectionincludes two discrete light sources that each emit near infrared lightand the reflected light detection section includes two bands ofdetection elements that are separated from the discrete light sources attwo different distances to detect the reflected light. The two bands ofdetection elements are arranged so that each band of detection elementsare positioned so as to detect reflected light coming from the twodifferent depths inside the head, corresponding to two sensitivity bandsinside the head. In further embodiments, one of the emitted lightspenetrates the skull and the other of the emitted lights penetratesfurther inside the skull so as to in effect interrogate the subarachnoidregion.

In yet further embodiments, such methods further include moving theemitter and the reflected light detection section along an externalsurface of the tissue from a start to an end position, where saidmeasuring includes measuring the reflected light in a time sequenceduring said moving. Such methods also include successively determiningin the time sequence, positions of the emitter and reflected lightdetection section with respect to the tissue during said moving from thefirst position to the end position.

In yet further embodiments, such methods include creating a volumetricimage using the acquired time sequence of measured reflected lightcorresponding to the two depths and the determined positions in a timesequence.

In yet further embodiments, such a step of obtaining includes obtaininga ratiometric measure of the reflected light corresponding to the twodepths of penetration for each time sequenced acquired reflected light.Also such a step of determining includes determining from each obtainedratiometeric measure of the time sequenced acquired reflected light oneof (a) the presence of the blood event, (b) the absence of the bloodevent, or (c) the possibility of the presence of a blood event.

In the case where it is determined that there is a possibility of ablood event, the medical personnel can perform additional testing orscreening, including using a more sophisticated imaging technique (e.g.,MRI, CAT) to determine the presence of a hematoma. In this way, themethods of the present disclosure can be used in appropriate settings totriage injured people so as to allow the medical personnel to determinewho does or does not require further screening or imaging to determinelocation and other features of a hematoma as well as the type ofhematoma and thus also providing an indicator of the possible severityof the injury. Such information also can be used to determine the needto risk immediate evacuate a person on a battlefield or accident site aswell as the mode of transportation.

According to another aspect of the present disclosure, there is featuredanother method for detecting a hematoma in tissue of a patient. Such amethod includes emitting near infrared light continuously into thetissue from a non-stationary near infrared light emitter andcontinuously monitoring the tissue using a non-stationary probe so as tocontinuously detect reflected light. The near infrared light is emittedat two distances from a brain of the patient, so the emitted lightpenetrates to two different depths. Such a method also includes applyinga ratiometric analysis to the reflected light to distinguish a borderbetween normal tissue and tissue exhibiting blood accumulation.

In further embodiments, such methods include applying a ratiometricanalysis to the reflected light to distinguish a border between normaltissue and tissue exhibiting blood accumulation. Such a ratiometricmeasure is representative of a ratio of densities representing thereflected light of the two different depths.

In further embodiments, the non-stationary emitter is configured andarranged so as to emit light having a wavelength at or about a firstwavelength, for penetrating to one of the two distances and to emit alight having another wavelength at or about a second wavelength, forpenetrating to the other of the two distances. Also, the non-stationaryprobe is configured and arranged to separately detect reflected lightcorresponding to the first wavelength and reflected light correspondingto the second wavelength.

In yet more particular embodiments, the emitting section includes twodiscrete light sources that each emit near infrared light and thedetection section includes two bands of detection elements that areseparated from the discrete light sources at two different distances todetect the reflected light. The two bands of detection elements arearranged so that each band of detection elements are positioned so as todetect reflected light coming from the two different depths inside thehead, corresponding to two sensitivity bands inside the head. In furtherembodiments, one of the emitted lights penetrates the skull and theother of the emitted lights penetrates further inside the skull so as toin effect interrogate the subarachnoid region.

According to yet another aspect of the present disclosure, there isfeatured an apparatus for detecting a hematoma in tissue of a patient.Such an apparatus includes a detection device that emits near infraredlight into the tissue and which provides outputs correspond to detectedreflected light and an analysis section operably coupled to thedetection device that determines at least the presence of a blood eventfrom the detection device outputs. In yet more particular embodiments,the analysis section is configured and arranged to apply a ratiometricanalysis to the reflected light to distinguish between normal tissue andtissue containing accumulated blood.

Such a detection device includes a near infrared light emitting sectionand a detection section. The near infrared light emitting section isconfigured and arranged so the near infrared light is emitted at twodistances from a brain of the patient and so the emitted lightpenetrates to two different depths. The detection section is configuredand arranged so as to separately detect reflected light from the twodifferent depths.

In yet further embodiments, the near infrared light emitting section isconfigured and arranged so as to emit light at or about a firstwavelength, for penetrating to one of the two different depths and toemit a light at or about a second wavelength, for penetrating to theother of the two different distances. Also, the detection section isconfigured and arranged to separately detect reflected light at or aboutthe first wavelength and reflected light at or about the secondwavelength.

In yet more particular embodiments, the emitting section includes twodiscrete light sources that each emit near infrared light and thedetection section includes two bands of detection elements that areseparated from the discrete light sources at two different distances todetect the reflected light. The two bands of detection elements arearranged so that each band of detection elements are positioned so as todetect reflected light coming from the two different depths inside thehead, corresponding to two sensitivity bands inside the head. In furtherembodiments, one of the emitted lights penetrates the skull and theother of the emitted lights penetrates further inside the skull so as toin effect interrogate the subarachnoid region.

In yet further embodiments, the detection device further includes aplurality of tracking mechanisms that each continuously provide in atime sequence outputs as the detection device is moved along an externalsurface of the tissue. The analysis section is further configured andarranged so as to determine time sequenced positions of the detectiondevice from the time sequenced outputs from the tracking mechanisms.

In yet further embodiments, such an apparatus further include an imagingsection operably coupled to the analysis section. The analysis sectionprovides outputs corresponding to the determined time sequencedpositions of the detection device. The imaging section is configured andarranged to provide a volumetric image using the acquired time sequenceof measured reflected light corresponding to the two different depthsand the determined time sequence positions.

While the methods, apparatuses and devices of the present disclosure aredescribed in connection with detecting and localizing hematomas, thedetection device, methods and apparatuses of the present disclosure areadaptable for use to detect any heavy optical contrast agent that islocated in a near surface (few diffusion lengths) of an object or asubsurface location of an object.

Other aspects and embodiments of the disclosure are discussed below.

Definitions

The instant disclosure is most clearly understood with reference to thefollowing definitions:

Unilateral hematoma shall be understood to mean a hematoma inside thehead and in which blood collection or accumulation takes place on oneside of the head.

Bilateral hematoma shall be understood to mean a hematoma inside thehead and in which blood collection or accumulation takes place on bothsides of the head.

An epidural hematoma shall be understood to mean a hematoma inside thehead and where the blood collects or accumulates outside the brain andits fibrous covering, the dura, but under the skull.

A subdural hematoma (SDH) shall be understood to mean a hematoma insidethe head and where the blood collects or accumulates between the brainand its dura.

An intracerebral hematoma shall be understood to mean a hematoma insidethe head and where the blood collects or accumulates in the braintissue.

A subarachnoid hematoma or hemorrhage (SAH) shall be understood to meana hematoma inside the head and where the blood collects or accumulatesaround the surfaces of the brain, between the dura and arachnoidmembranes.

The term patient shall be understood to include mammalians includinghuman beings as well as other members of the animal kingdom.

USP shall be understood to mean U.S. patent Number, namely a U.S. patentgranted by the U.S. Patent and Trademark Office.

As used in the specification and claims, the singular form “a”, “an” and“the” include plural references unless the context clearly dictatesotherwise.

ASIC shall be understood to mean application specific integratedcircuit.

BRIEF DESCRIPTION OF THE DRAWING

For a fuller understanding of the nature and desired objects of thepresent dislosure, reference is made to the following detaileddescription taken in conjunction with the accompanying drawing figureswherein like reference character denote corresponding parts throughoutthe several views and wherein:

FIGS. 1A and 1B are illustrative views of the general anatomicalconfiguration of the skull of a human.

FIG. 2 is a schematic block diagram view of an apparatus according tothe present disclosure for detecting a hematoma and including a handhelddetector according to the present disclosure.

FIG. 3 is an illustrative bottom view of the imaging head portion orimaging section of a handheld detector according to the presentdisclosure.

FIG. 4 is an illustrative view showing a handheld detector according tothe present disclosure when disposed on a head of a patient.

FIG. 5 is an illustrative view of a portion of a head and a handhelddetector according to the present disclosure to illustrate theratiometric aspect embodied in the detector and methods of the presentdisclosure.

FIG. 6 is another illustrative view of imaging a portion of the headusing the handheld detector according to the present disclosure.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the various figures of the drawing wherein likereference characters refer to like parts, there is shown in FIGS. 1A and1B illustrative views of the general anatomical configuration of theskull of a human. As shown, three membranes are located between theskull and the brain which serve to cushion and protect the brain. Theselayers are the dura matter (dura), the arachnoid and the pita mater(pita). These three membranes envelope the brain.

The pia is delicate and vascular, the arachnoid is thin and separatesthe pia from the dura. The dura is a tough fibrous membrane thatenvelopes the brain and its more delicate structures. When the vesselsof the pia are rupture such as a result of trauma or other reason, theescaping or leaking blood accumulates in a localized fashion within theseries of membranes to form either a SAH or SDH. Because the skullshields the area where the blood is accumulating, an EMT, clinician oremergency room personnel cannot detect the presence of the hematoma (SAHor SDH) by routine visual inspection. Thus, as indicated herein an SDHfor example could go undetected during such a routine visual inspectionand could lead to severe consequences.

In its broadest aspects the present disclosure features methods fordetecting hematomas more particularly hematomas inside the skullincluding SAH and SDH as well as being able to identify the particulartype of hematoma. The present disclosure also features devices,apparatuses and systems for detection and/or visualizing such hematomas.As described herein, in more particular embodiments the detection deviceis preferably hand held so as to allow the use of the device in aclinical setting and a non-clinical setting (e.g., rural, battlefield,accident site) by people having a wide range of qualifications (e.g.,emergency room personnel, EMTs, medics).

Such methods, devices, apparatuses and systems of the present disclosureutilize the properties of diffuse tissue optics to detect and determinethe presence of hematomas. In diffuse tissue optics, it is known thatblood accumulating in tissue causes a contrast shift in back reflectedlight from the tissue. In prior art techniques, people have been tryingto use such measures for complex issues such as neuro-imaging of subtlechanges for cancer detection. In the present disclosure, however, one islooking for a very gross change in tissue blood volume which is what onewould expect in the case of a hematoma.

Such a detection device also advantageous allows the user (doctor, EMT,medic, or medical personnel) to determine at a scene of an accident, inan emergency room or other locations, where there is limited to no readyaccess to a CT scanner, to diagnose whether a patient with a traumaticbrain injury has sustained a hematoma and also allow the user todetermine if the hematoma is subdural or epidural. Moreover, suchmethods, devices an apparatuses of the present disclosure are such as toallow the user to transfer data and/or information to a computer such asfor example a laptop, to create a 3d surface image of the scannedvolumes and or so as to allow the user to have the location of thehematoma to be displayed.

Such methods, apparatuses and systems of the present disclosure alsoembody a detection device that collects data for detecting a hematoma,as it is being moved along the outer surface of head. In conventionaltechniques or methods, data is collected using a stationary probe thathas to repositioned at different locations for data acquisition.

Such methods, devices, apparatus and/or systems also provide a mechanismby which medical personnel, EMTs, medics and the like can screen ortriage patients or victims having head injuries. Such screening ortriage should allow the personnel to determine those patients who shouldundergo more sophisticated imaging procedures (e.g., CAT scan), as wellmaking an assessment as to the as the severity of the possible injury todetermine, if necessary the order in which patients will be imaged.

Referring now to FIG. 2 , there is shown a schematic block diagram viewof an apparatus 300 or system according to the present disclosure fordetecting hematoma, which apparatus 300 includes a detector 100 and amedical station 200 or data processing station according to the presentdisclosure. The medical station 200 is operably and communicativelycoupled to the detector 100 using any of a number of techniques known tothose skilled in the art so that the data that was acquired by thedetector 100 is communicated to the medical station. As describedfurther herein, in further embodiments such transferred data isprocessed and/or manipulated to generate or create a volumetric image ofthe volume which had been scanned for observation by medical personnel.The medical station 200 also is configurable so the transferred dataand/or the created volumetric image is uploaded into the medical recordsfor the patient or otherwise saved for record keeping purposes.Reference also is made to FIG. 3 which provides an illustrativeexemplary bottom view of the imaging head portion or imaging section 110of a detector 100 according to the present disclosure.

The detector 100 includes an imaging section 110 and a control andmonitoring section 150 that is operably and communicatively coupled tothe imaging section. In one embodiment, the imaging section and thecontrol and monitoring section are arranged so as to form a unitarystructure that is preferably arranged so that the detector 100 ishandheld, such as shown in FIG. 4 . In such an application, and asillustrated in FIG. 4 , the bottom surface of the detector 100 is laidonto the head of the patient such that the user can move the detectorlaterally across the scalp of the head while continuously collectingimage data as described further herein. In such an application, thedetector 100 includes a power supply (not shown) such as a battery or acapacitor in which is stored energy sufficient to perform the imagingprocess.

In another embodiment, the detector 100 is formed in two separate parts,the imaging section 110 and the control and monitoring section 150. Inthis embodiment, the imaging section 110 is configured so as to behandheld and also so as to be moved along the scalp of the patient muchas described above. In this embodiment, the control and monitoringsection 150 is operably coupled to the imaging section 110 using one ormore optical or electrical cables 160, 162 so that the control andmonitoring section is remote from the imaging section.

In one illustrative embodiment, the control and monitoring section 150is disposed in a housing or structure that is secured about the waist ofthe user. As with the other above-described embodiment, the power supply(not shown) is embodied within the control and monitoring section 150 oris housed in a separate structure. Alternatively, the control andmonitoring section 150 is remote from the imaging section 100 and isdisposed, for example, on a table or platform. The control andmonitoring section 150 also is operably coupled to the imaging sectionby cables 160, 162. In this alternative embodiment, the power supply isportable as described above or the control and monitoring section 150 isarranged so as to receive power from a stationary power supply.

The control and monitoring section 150 includes the electronics andfunctionalities that control the operation of the imaging section 110,to control acquisition of image data from the imaging section, toperform the calculation procedures and/or techniques for determining thepresence of a hematoma as well as the type of hematoma and providingvisual queues to the user to indicate the presence or lack thereof of ahematoma. In more particular embodiments, the control and monitoringsection 150 includes processing circuitry 152 as is known to thoseskilled in the art that is configurable to perform the above describedfunctions as well as control data or information transfer between themedical station 200 and the detector 100.

As is known to those skilled in the art such processing circuitry 152includes a processor or other circuit element (e.g., ASIC), RAM, and oneor more software programs that is/are executed in the processor so as toperform the control and processing functions of the medical station. Thecontrol and monitoring section also can be configured so as to beoperably coupled to any of a number of ancillary devices orfunctionalities, such as for example, a keyboard, mouse, pointer, voicerecognition input device and the like that provide a mechanism to allowthe user to update the software or setup the detector 100 so it canperform the imaging process for a given patient while taking intoaccount any patient parameters or environmental conditions so as tooptimize the data acquisition process. Such a control and monitoringdevice also is configurable so as to be operably coupled to a displaydevice, such as described below foe use in connection with the use of anancillary device.

The control and monitoring section 150 also includes one or morecommunication mechanisms 154, 156 that are operable coupled to theprocessing circuitry 152 so that the processing circuitry can receiveand/or transmit data or information. In illustrative embodiments, thecontrol and monitoring section 150 includes an I/O port(s) 154 as isknown to those skilled in the art, whereby the detector 100 can beoperably and communicatively coupled to the medical station 200. Inexemplary embodiments, the I/O port 204 is a USB or firewire type of I/Oport so that the detector 100 can be connected to the medical station200 via a hard line 220.

In further illustrative embodiments, the control and monitoring section150 includes a wireless transmission device 156, such as for example andtransceiver and an antenna, that communicates with the detector withoutthe need for a hardline. Such a transmission device 156 is operablycoupled to a complimentary transmission device 206 provided with themedical station 200. In further embodiments, such transmission devices206, 156 utilize RF or IR signal techniques for communication. In moreparticular embodiments, the transmission devices embody well knownbluetooth transmission techniques for such wireless communications. Italso should be recognized that while the detector 100 is composed of twoparts, a control and monitoring section 150 and an imaging section 110,it is within the skill of those knowledgeable in the arts to configureeach so as to embody wireless communication techniques to transmitand/or receive communication commands, data and/or information betweenthe two sections.

In further embodiments, the imaging section 110 is configured so as toinclude a plurality, more particularly three or more tracking devices116 (see FIG. 3 ) that are arranged and configured so as to provide dataor information back to the control and monitoring section 150, morespecifically the processing circuitry 152 thereof. In illustrativeembodiments, the tracking devices are rollerballs as are known to thoseskilled in the art. The motion of the rollerballs is tracked as thedetector 100, more specifically the imaging section 110 thereof, movesalong the scalp of the head 2. In more particular embodiments, such atrackball system embodies a Kahlman filter so as to allow for the motionof the three points corresponding to gradually refine and improve theestimate of the geometry. In more particular embodiments, the processingcircuitry 152 of the control and monitoring section 150 includes asoftware program embodying any one of a number of algorithms known tothose skilled in the art, which can develop the tracking informationcorresponding to the movement of the rollerballs 116 and thus themovement of the imaging section 110.

As indicated herein, the tracking data from movement of the rollerballsalong the surface of the scalp 4 (FIG. 5 ) in conjunction with the databeing acquired as the imaging section 110 moves along the scalp isinputted to the medical station 200. Such information is used to developa three dimensional image of the head 2 and the volume that was imagedso that a user is provided with a display of the head and any trauma.

Such an imaging section 110 also includes a light source 112, an arrayof detection elements 114 and a light skirt 120 (FIG. 3 ) that extendsabout the periphery of the imaging section 110. The light skirt 120 isprovided and arranged so as to shield the array of detection elements114 from light that is external to the imaging section 110.

In more particular embodiments and as more clearly shown in FIGS. 3 and6 , the light source 114, is configured and arranged so as to includetwo discrete light sources 112 a,b that each emit near infrared light170 a,b and two bands of detection elements 114 a,b that are separatedfrom the light sources 112 a,b at two different distances to detectreflected light 180 a,b. In more particular embodiments, each of thelight sources 112 a,b is a light emitting diode (LED) emitting light atabout a specified wavelength of near infrared light. The light isemitted at two distances from the brain such that the emitted lightpenetrates to two different depths.

In yet more particular embodiments, the two light sources 112 a,b areselected such that they respectively emit near infrared light at abouttwo different wavelengths, a first wavelength and a second wavelength.In more illustrative embodiments, the first wavelength and the secondwavelength are on either side of 800 nm and in more particularillustrative embodiments, the first wavelength is in a range that islonger than 800 nm and the second wavelength is the range that isshorter than 800 nm. In exemplary embodiments, the first wavelength isat about 850 nm and the second wavelength is at about 850 nm. Asindicated above, the two bands of detector elements 114 a,b are arrangedso that each band of detector elements 114 a,b are positioned so as todetect reflected light 180 a,b coming from the two different depthsinside the head 2, corresponding to two sensitivity bands 190 a,b insidethe head. In further embodiments, one of the emitted light 170 apenetrates the skull 4 and the other of the emitted light 170 bpenetrates further inside the skull so as to in effect interrogate thesubarachnoid region.

In the present disclosure, the reflected light 180 a,b from the twodifferent penetration depths is separately detected by the imagingsection 110 and the data corresponding to these two different depths ordistances is inputted to the control and monitoring section 150 forprocessing. The processing circuitry 152 is configured so as to use aratiometric measure or analysis to detect major blood events (e.g.,hematomas) inside the head 2. Such a ratiometric analysis or analysis isused to distinguish the border between normal tissue and tissue in whichblood is accumulating, in other words hematoma containing tissue. Theratiometric analysis is a ratio of the densities representing the twodepths of penetration.

Such an analysis is performed using any of a number of mathematicaltechniques known in the art. In one illustrative embodiment, the opticaldensity data from the detector element bands 114 a,b is analyzed using alevel set method, which is sequentially alternated with a standardmatrix inversion. In another illustrative embodiment, a multi-gridapproach is used to analyze such optical density data. The multi-gridapproach can be advantageous as it should improve the speed of analysis.In further embodiments, noise filtering is applied in either the forwardor reverse domain and is selected based upon the expected or discoverednoise characteristics.

In use after the detector 100 or imaging section 110 thereof ispositioned on the scalp/skull 4 of the patient, the control andmonitoring section 150 controls operation of the imaging section so asto cause the light sources 112 a,b to continuously emit the nearinfrared light 170 a,b and so that the reflected light 180 a,b iscontinuously monitored by the detector element bands 114 a,b.

Also, according to methodology of the present disclosure, the detector100 or imaging section 110 thereof is moved (see FIG. 6 ) in a directiontransverse to the scalp/skull 4 from a start position to a final or endposition. As the detector or imaging section is being so moved, thecontrol and monitoring section 150 causes the imaging section tocontinuously emit the near infrared light 170 a,b, to continuouslymonitor the reflected light 180 a,b using the detector element bands 114a,b and to continuously perform a ratiometric analysis of the acquiredoptical data at the two different distances.

In further embodiments, the control and monitoring section 150 furtherevaluates the determined ratio against threshold criterion so as todetermine if the tissue is hematoma containing, not hematoma containingor suspect as being possibly hematoma containing tissue. The thresholdvalues are determined using any of a number of techniques known to thoseskilled in the art. In illustrative embodiments, the threshold valuesare based on clinical data. In yet further embodiments, a plurality ofthreshold values are established each being representative of adifferent patient type, nationality, race and or hair color. In use, theuser would initially configure the detector so that the appropriatethreshold criterion are used by the control and monitoring section 150.

In yet further embodiments, the control and monitoring section 150 isconfigured to control operation of the imaging section 110 so that datacorresponding to the reflected light 180 a,b in the two sensitivitybands 190 a,b is outputted in a time sequence to the control andmonitoring section. Such data in a time sequence is analyzed by thecontrol and monitoring section 150 to determine if the tissue ishematoma containing, not hematoma containing or suspect as beingpossibly hematoma containing tissue.

In yet further embodiments, the control and monitoring section 150includes a plurality of lights or visual indicators 158 a-c, that areresponsive to control signals from the processing circuitry 152. Whenthe control and monitoring section 150 determines from the optical datathat the threshold criterion indicating the presence of hematomacontaining tissue is satisfied, the processing circuitry causes one ofthe visual indicators 158 a to be actuated thereby providing a visualqueue to the user of the presence of a hematoma. In an illustrativeembodiment, the visual indicator 158 a outputs red light as a warning orindictor of a hematoma.

In the case where it is determined that the tissue does not contain ahematoma, then the processing circuitry causes another one of the visualindicators 158 b to be actuated thereby providing a visual queue to theuser that the tissue is normal or not containing a hematoma. In anillustrative embodiment, the visual indicator 158 b outputs green lightas in indicator of this tissue condition.

There may be cases where the optical data cannot provide a cleardetermination that the tissue is or is not hematoma containing tissue.In such cases, the processing circuitry causes yet another one of thevisual indicators 158 c to be actuated thereby providing a visual queueto the user that the tissue is suspect or possibly being hematomacontaining tissue. In an illustrative embodiment, the visual indicator158 c outputs another colored light signal (e.g., amber colored) lightas in indicator of this tissue condition.

In use, the user can use these three different visual indicators 158 a-cas a mechanism to determine what further action should be taken. Forexample, in the case where it is determined that the tissue being imagedis suspect as possibly being hematoma containing tissue, the user couldorder further scanning using an appropriate scanner (e.g., MRI or CTscanner) which should be capable of resolving the hematoma containingtissue concern.

Referring now back to FIG. 3 , the medical station 200 includesprocessing circuitry 210 that controls operation and functioning of themedical station and the imaging section as well as allowing the user tomanipulate and control processing of the optical data and the results ofsuch processing. As is known to those skilled in the art such processingcircuitry 21 includes a processor or other circuit element (e.g., ASIC),RAM, and one or more software programs that is/are executed in theprocessor so as to perform the control and processing functions of themedical station. The medical station also can embody any of a number ofancillary devices or functionalities, such as for example, a keyboard,mouse, pointer, voice recognition input device and the like that providemechanisms that allow the user to input commands and additionalinformation as well as to manipulate and visualize data

In further embodiments, the medical station 200 includes any of a numberof displays 212 that are known to those skilled in the art orhereinafter developed, whereby a visual picture or image can beprojected by the display and observed by the user. In exemplaryembodiments, such displays include; liquid crystal displays, CRT andplasma screens. In particular embodiments, the created volumetric imageis shown using the display 212. Also, the user can use the appropriateancillary devices to manipulate the volumetric image so as to rotateand/or translate the image so the user can observe the image fromdifferent angles or points of view.

In further embodiments, the medical station 200 includes one or morecommunication mechanisms 204, 206 that are operable coupled to theprocessing circuitry 210 so that the processing circuitry can receiveand/or transmit data or information. In illustrative embodiments, themedical station 200 includes an I/O port(s) 204 as is known to thoseskilled in the art whereby the detector 100, more specifically an I/Oport 154 thereof, can be operably and communicatively coupled to themedical station. In exemplary embodiments, the I/O port 204 is a USB orfirewire type of I/O port so that the detector 100 can be connected tothe medical station via a hard line 220.

In a further illustrative embodiment, the medical station includes awireless transmission device 206, such as for example and transceiverand an antenna, that communicates with the detector without the need fora hardline. Such a transmission device 206 is operably coupled to acomplimentary transmission device 156 provided with the detector 100. Infurther embodiments, such transmission devices 206, 156 utilize RF or IRsignal techniques for communication. In more particular embodiments, thetransmission devices embody well known bluetooth transmission techniquesfor such wireless communications.

In yet further embodiments, the medical station 200 and/or the detector100 are configured so as to include an I/O port or wirelesscommunication device that allows either or both of the medical stationor the detector 100 to be operably and communicatively coupled to anetwork (e.g., WAN, LAN). In one illustrative example, the detector 100and the medical station are each operably coupled to the wired orwireless network using the appropriate techniques and after being socoupled the detector downloads information and/or data to the medicalstation via the network connections. In another illustrative example,the medical station 200 is operably coupled to the network such thatdata, information or volumetric image data can be uploaded to medicalrecords.

It is well within the skill of those knowledgeable in the computer orsoftware arts that the structure of the logic of the differentmethodologies/inventions described herein can be embodied in computerprogram software for execution on a computer, digital processor ormicroprocessor. Those skilled in the art will appreciate the structuresof the computer program code elements, including logic circuits on anintegrated circuit, that function according to the present disclosure,can be developed from the described structure of the logic of thedifferent methodologies/inventions described herein. As such, thepresent disclosure is practiced in its essential embodiments by amachine component that renders the program code elements in a form thatinstructs a digital processing apparatus (e.g., computer) to perform asequence of function step(s) corresponding to the functions andoperations of the detector 100 and medical station 200 of the presentdisclosure as described herein.

Although a preferred embodiment of the disclosure has been describedusing specific terms, such description is for illustrative purposesonly, and it is to be understood that changes and variations may be madewithout departing from the spirit or scope of the following claims.

INCORPORATION BY REFERENCE

All patents, published patent applications and other referencesdisclosed herein are hereby expressly incorporated by reference in theirentireties by reference.

EQUIVALENTS

Those skilled in the art will recognize, or be able to ascertain usingno more than routine experimentation, many equivalents of the specificembodiments of the disclosure described herein. Such equivalents areintended to be encompassed by the following claims.

What is claimed is:
 1. A system for detecting a hematoma in tissue of apatient, the apparatus comprising: a detection device that emits nearinfrared light into the tissue and which provides outputs thatcorrespond to detected reflected light the detection device including: anear infrared light emitting section that is configured and arranged sothe emitted near infrared light penetrates to two different depthswherein a first depth is above the subarachnoid region of the patientand a second depth is below the subarachnoid region of the patient, thenear infrared light emitting section includes separate first and secondlight sources wherein the first light source emits infrared light thatpenetrates the first depth above the subarachnoid region and the secondlight source emits infrared light that penetrates the second depth belowthe subarachnoid region of the patient wherein the first light has awavelength longer than 800 nm and the second light has a wavelengthshorter than 800 nm, and a detection section that is configured andarranged so as to separately detect reflected light from the twodifferent depths; and wherein the system is configured to apply aratiometric analysis to the reflected light that is detected while thedetection device is moved along an external surface of the tissue todistinguish between normal tissue and tissue containing accumulatedblood.
 2. The system of claim 1, wherein: the detection section isconfigured and arranged to separately detect reflected light at or aboutthe first wavelength and reflected light at or about the secondwavelength.
 3. The system of claim 1, wherein: the detection devicefurther includes a plurality of tracking devices that each continuouslyprovide time sequenced tracking data of the detection device as it ismoved along an external surface of the tissue; and wherein the system isfurther configured and arranged so as to determine time sequencedpositions of the detection device from the time sequenced tracking datafrom the tracking devices.
 4. The system of claim 3, further comprising:an imaging section operably coupled to the analysis section; wherein thesystem provides outputs corresponding to the determined time sequencedpositions of the detection device; and wherein the imaging section isconfigured and arranged to provide a volumetric image using the acquiredtime sequence of measured reflected light corresponding to the twodifferent depths and the determined time sequence positions.
 5. Thesystem of claim 1, wherein the detection system includes separate firstand second detection elements wherein the first detection elementdetects light reflected from the first depth above the subarachnoidregion and the second detection element detects light reflected from thesecond depth below the subarachnoid region of the patient.
 6. The systemof claim 5, wherein the first detection element includes a plurality ofdetection element bands.
 7. The system of claim 6, wherein the seconddetection element includes a plurality of detection element bands. 8.The system as recited in claim 1, wherein the detection device consistsof a first imaging section including the infrared light emitting sectionand the detection system and a separate second control monitoringsection for applying the radiometric analysis to the reflected lightreceived by the separate first imaging section.
 9. The system as recitedin claim 8, wherein the first imaging section is wirelessly coupled tothe separate second control monitoring section.
 10. A system fordetecting a hematoma in tissue of a patient, the apparatus comprising: adetection device that emits near infrared light into the tissue andwhich provides outputs that correspond to detected reflected light thedetection device including: a near infrared light emitting section thatis configured and arranged to simultaneously emit first and secondinfrared lights wherein the first infrared light penetrates a firstdepth above the subarachnoid region of the patient and the secondinfrared light penetrates a second depth below the subarachnoid regionof the patient wherein the first light has a wavelength longer than 800nm and the second light has a wavelength shorter than 800 nm; and adetection section that is configured and arranged so as to separatelydetect reflected light from the two different depths wherein the systemis configured to apply a ratiometric analysis to the reflected lightthat is detected while the detection device is moved along an externalsurface of the tissue to distinguish between normal tissue and tissuecontaining accumulated blood.
 11. The system of claim 10, wherein thenear infrared light emitting section includes separate first and secondlight sources wherein the first light source emits the first infraredlight that penetrates the first depth above the subarachnoid region andthe second light source emits the second infrared light that penetratesthe second depth below the subarachnoid region of the patient.
 12. Thesystem of claim 11, wherein the detection system includes separate firstand second detection elements wherein the first detection elementdetects light reflected from the first depth above the subarachnoidregion and the second detection element detects light reflected from thesecond depth below the subarachnoid region of the patient.
 13. Thesystem of claim 11, wherein the first detection element includes aplurality of detection element bands.
 14. The system of claim 13,wherein the second detection element includes a plurality of detectionelement bands.
 15. The system as recited in claim 10, wherein thedetection device consists of a first imaging section including theinfrared light emitting section and the detection system and a separatesecond control monitoring section for applying the radiometric analysisto the reflected light received by the separate first imaging section.16. The system as recited in claim 15, wherein the first imaging sectionis wirelessly coupled to the separate second control monitoring section.